STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESS LAPAROSCOPIC URETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL

PROTOCOL OF THESIS FOR THE DEGREE OF DIPLOMATE OF NATIONAL BOARD

(GENERAL SURGERY)

SUBMITTED TO

NATIONAL BOARD OF EXAMINATIONS, NEW DELHI

SUBMITTED BY

DR. AKRITI

DNB (TRAINEE)

DEPARTMENT OF GENERAL AND MINIMALLY INVASIVE SURGERY

NAZARETH HOSPITAL

SHILLONG, LAITUMUKHRAH

793003

PHONE: 0364-2224052 / 2210188

UNDER THE GUIDANCE OF

GUIDE                                                                                                  CO-GUIDE                  

SYNOPSIS

•       The purpose of this study is to evaluate the need of ureteral stenting after Laparoscopic Ureterolithotomy. This randomized controlled study will compare the outcome of placing ureteral stent in one group while no stent placement in another group.

•       Demographic details & investigation reports will be collected pre-operatively followed by laparoscopic ureterolithotomy with or without DJ stent placement as per randomisation.

•       Intra and Post-operative data collection will be done according to pre-defined parameters, followed by comparison and statistical analysis of the outcomes in the respective groups to arrive at a conclusion.

INTRODUCTION

Urolithiasis and its management have become a global growing concern posing both clinical and economic burden for healthcare systems. With the steady rise of populations, the annual prevalence of urinary tract stones is increasing and as well as the requirement for hospital visits. Ureter stone has a lifetime prevalence of 10% to 15% and is one of the most common urological presentations. (1)

Patients experience severe flank pain radiating to groin because of sudden obstruction of the ureter, with associated risks of hydronephrosis, renal damage, infection of the urinary tract and severe sepsis. Ureteric stones can be managed by different modalities; expectant management with spontaneous passage of the stone, with or without medical expulsive therapy as an adjuvant. Those that fail to pass stones spontaneously will require more invasive options.(1)

Shock wave lithotripsy (SWL) and ureteroscopy (URS) are the most commonly preferred methods for the treatment of ureteral stones. However, their use for large upper and middle ureteral stones remains controversial. Particularly with impacted stones, the success rate of SWL and URS diminishes, and when the stone size exceeds 1 cm, SWL efficacy decreases from 84 to 42%. (2)

Although 7% of the ureteral stones treated with endourological methods require repeated treatment, 1% –10% of such patients may need open surgery. Open surgery has the advantage of a high success rate in one session for such complicated patients. Because open surgery increases the length of hospital stay and requires additional analgesic treatment for the patient, laparoscopic ureterolithotomy (LU) has recently become an alternative management method. It has been proposed that the success rate of LU is similar to that of open surgery but it is superior to open surgery in reduced analgesic requirement, hospital stay, recovery, and cosmetic outcome.(2)

The first use of a double-J stent (DJ stent) was reported by Zimskind et al. in 1967. Since then, after any open or endoscopic urological procedure, short duration placement of ureteric DJ stent has become almost routine. Of course, over the last few years, there is controversy on whether a DJ stent should routinely be kept after laparoscopic ureterolithotomy (LU). (3)

Despite the rapid development of surgical techniques, there are still some debates about whether it is necessary to place a urinary stent to drain, and which type of stent is better. However, which is superior among DJ stented and stent-less procedures remains unclear. Even though many studies have compared the differences between these procedures, no clear conclusions have been drawn. Nowadays, Whether or not to place stents and which type of stents to place in clinical practices mainly depends on the surgeons’ preference and experience. (4)

Complications of DJ stent:

·       Urinary tract infections

·       Stent migration

·       Stent fracture

·       Stent encrustation

·       Forgotten stent

·       Need for a second procedure

NEED FOR THE STUDY

Even though previous studies have compared the differences between stented and stentless laparoscopic ureterolithotomy, no clear conclusions have been drawn. More studies in this discipline are needed owing to the lack of consensus to indicate the use of ureteral stents post ureterolithotomy.

REVIEW OF LITERATURE

Key words used :

Ureterolithotomy (595 results)

Stentless (461 results)

DJ Stent ureterolithotomy ( 6 results)

Stentless ureterolithotomy India ( 1 result)

Filters used:

Up to 10 years

Meta-analysis

·       Five of the few studies done on adults similar to my title have been tabulated and one Indian study done on pediatric population has been separately mentioned in the text following.

Currently published literature related to these studies have been tabulated below:

STUDY 1)

Results: All procedures were performed successfully. The mean operative time was 48 minutes in group 1 vs 65 minutes in group 2. The mean drainage time was 4.1 days in group 1 vs 2.3 days in group 2. All the patients were followed up for a period of 6 months with no recorded cases of residual stone or ureteral stricture.

STRENGTH: The operation was performed by the same surgeon

WEAKNESS:

·       The methodology of randomization not mentioned.

·       The longer operative time was attributed to positioning of the patient before stent insertion i.e. stenting time not considered separate entity

STUDY 2)

Results: The groups were similar as for age and gender, degree of dilation of the urinary tract, position and average size of the calculi (Group 1 = 15.5 ± 6.6 mm, Group 2 = 16.3 ± 6.1 mm). Operative time was also not significantly different (Group 1 = 130 ± 40.3 min, Group 2 = 136.3 ± 49.3 min). Group 1 had six patients (37.5%) with early (four cases of urinary fistula) and late complications (one case of stenosis of the ureter, one case of functional exclusion of the operated kidney), while Group 2 had no complications, This difference was statistically significant (p = 0.011).

STRENGTH:

·        Pre-operative and post-operative serum creatinine and IVU was done

·       Analgesic use defined post-operative day wise

WEAKNESS:

Greater amounts of analgesics used than the series in the literature.

The authors thus consider the effective control of pain, the reason for shorter hospitalization time.

STUDY 3)

Results: In one case, the stone was pushed back. The stone-free rate was 97.8%. There were four cases of prolonged urinary leakage after the surgery. All of them were in the group in whose members the Double J catheter had not been placed. The problem was resolved in one patient spontaneously after 4 days, but for the other three patients, a Double J catheter was placed and the leakage was stopped in 24 hours. There was no case of urinary leakage in the second group of patients with a placed Double J catheter.

STRENGTH: Single surgeon performed all the surgeries.

WEAKNESS: Study design unclear as first 23 patients underwent stentless surgery and next 23 receive stent successively (due to few complications observed in stentless group)

STUDY 4)

Results: The mean patient age, serum creatinine levels, and stone size were not significantly different between the two groups. The stone-free rate was 100%. The mean operative time was significantly shorter in the stentless group than in the stent group (59.48 minutes vs. 77.88 minutes, p＜0.001). Parenteral analgesic use and anticholinergic medication use were observed in the stent group only. The blood loss, drain removal day, and hospital stay were not significantly different between the two groups. No other significant complications occurred during or after the operation in any patients.

STRENGTH: Single surgeon performed all surgeries.

WEAKNESS: Lack of an imaging study such as ultrasonography or CT scans to confirm ureteral strictures in all the subjects

STUDY 5)

Results: Four studies with 289 participants were included in the study. There was no significant difference between two groups in rate of prolonged urine leakage (odds ratios [OR] 0.35, 95% confidence intervals [CI] 0.09–1.46, p = 0.15). Significant longer operative time was detected in patients who underwent stented LU compared with stentless group (mean difference 11.36, 95% CI 7.53–15.20, P < .00001). There was no significant difference between two groups in day of drain removal (mean difference -1.09, 95% CI -2.33–0.15, P = .08). No significant difference in blood loss in patients who underwent stented LU compared with stentless group was detected (mean difference 7.67, 95% CI -0.29–15.64, P = .06).

STRENGTH: Systematic review of already existing studies

WEAKNESS: A study on paediatric population was included along with 3 studies on adults for meta-analysis which might give false results.

STUDY 6)

Indian study:

Conducted at Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh 226010, India

Laparoscopic Ureterolithotomy in Children: With and Without Stent — Initial Tertiary Care Experience with More Than 1-Year Follow Up (10)

Method: Impacted ureteric stone of size 1.5 cm or ureteric stones that were refractory to shock wave lithotripsy (SWL)/ureteroscopy (URS) were considered for LU. From December 2009 to April 2012, 50 cases of LU were performed with a stent being placed. From May 2012 onward we now perform stentless LU and till now we have done approximately 64 such type of cases. Out of these, 48 have completed more than 1 year of follow-up and we took these as our study group and the previous 50 (LU with stent) as our control group. Baseline characteristics along with certain per- and postoperative findings of the two groups were noted and analyzed. Ultrasonography and X-ray kidney, ureter, and bladder region were done at 3, 9months, 1 year, and yearly thereafter. Intravenous urography was done at 6 months statistical analysis was performed by using SPSS ver. 21 (SPSS Inc., Chicago, Illinois, United States). The data were analyzed by using the Mann–Whitney test and a p value of < 0.05 was considered significant.

Results:  The baseline characteristics were similar in both the groups with 100% stone clearance in all. LU with stent differed from the stentless group in terms of more requirement of analgesics and the need for a second procedure for stent removal, but with no cases of urine leak in the postoperative period.

LACUNAE IN LITERATURE:

•       None of the studies have considered stenting time as a separate entity while establishing operative time for the stented group. Stenting time will vary with different stenting methods.

•       Not enough number of randomized controlled trials have been done.

•       Most of the studies have been done outside India. Also there are no studies in the north eastern part of the country where urolithiasis is largely prevalent.

RESEARCH QUESTION

IS LAPAROSCOPIC URETEROLITHOTOMY WITHOUT DJ STENT NON-INFERIOR TO DJ STENTED URETEROLITHOTOMY?

AIMS AND OBJECTIVES

To evaluate the outcomes of performing laparoscopic ureterolithotomy with and without DJ stent placement in patients of ureteric calculus/calculi in terms of:

·       operative time

·       nature and quantity of drain output

·       duration of drain removal

·       hospital stay in days

·       post-operative complications

MATERIALS AND METHODS

Approval of INSTITUTIONAL SCIENTIFIC COMMITTEE AND ETHICAL COMMITTEE has been taken as a pre-requisite. The study will be registered in the CLINICAL TRIALS REGISTRY OF INDIA. While conducting the study, informed written consent will be taken after explaining the need and importance of the study prior to filling of the patient’s proforma to rule out future conflicts. A detailed clinical history along with general and systemic examination and various relevant investigations will be done.

Study setting:

The study will be conducted in Nazareth Hospital, Shillong , Meghalaya - a tertiary care hospital

Study population:

Patients of ≥ 18 years of age who will be presenting with ureteric calculus/calculi undergoing laparoscopic ureterolithotomy and fulfilling inclusion criteria.

Study design:

The study will be a RANDOMIZED CONTROLLED TRIAL.

Inclusion criteria:

1)Patients who consent

2)Patients ≥ 18 years of age

3)Patients with ureteric calculus/calculi of size ≥ 1 cm

Exclusion criteria:

1. Pregnant patients
2. Stone associated with radiologically diagnosed ipsilateral stricture ureter.

Follow up period:

All patients to be followed up to a period of 3 months post-surgery.

Duration of study:

The duration of the sample collection will be from 1^st December 2020 to 30^th  November 2021 and all patients will be followed up till 3 months.

Sample size calculation:

The following study has been used to calculate sample size:

(8) You JH, Kim YG, Kim MK et al.

n= { 2 [Φ¯¹ (α) + Φ¯¹ (β)] ² σ²}

(μ1-μ2)²

Φ¯¹ = Cumulative distribution function for standardized normal variant.

 Î¼1 & μ2 = Mean outcomes in the 2 groups

where μ stands for mean duration of drain removal in the two groups , details of which are already mentioned in the review of literature.

P value will be calculated to establish the significance of  the parameter mentioned.

 Ïƒ=  Standard deviation

                                                                        α= 5%

                                                                Power= 80%

OPERATIONAL DEFINITION

SIZE OF STONE: The size of the stone will be defined in the greatest diameter measured. For this study stone size greater than or equal to 1cm will be considered.

Methodology:

Patient selection:

·       Patients  â‰¥  18 years diagnosed with ureteric calculus/calculi of size ≥ 1 cm will undergo randomization into 2 groups

·       Informed consent will be taken from all the patients undergoing surgery along with consent for stent placement before randomization.

·       BLOCK RANDOMISATION will be done in a combination of block of 6 & 4.

·       The randomization will be done on the previous evening of the day of surgery.

·       Pre formed opaque envelopes will be prepared with group name either A or B mentioned on the inside.

·       Envelop serial number, block identifier and block sequence will be mentioned on the outside in the sequence of block randomization.

·       Envelops will be dispensed successively to the selected patients serially.

·       The envelop will be opened by the patient himself/herself.

·       Group name will be recorded in the proforma sheet as per the result.

Surgery : All patients will undergo laparoscopic ureterolithotomy under general anesthesia.

Stent: Double- J stent made up of polyurethane will be used in all patients to be stented.

Surgeons: The surgeons performing surgery have experience greater than 100 cases.

Group with DJ Stent (GROUP A) : Patient in this group will have DJ stent insertion post laparoscopic ureterolithotomy on the corresponding side.

Group without DJ stent (GROUP B): Patient in this group will not have DJ stent insertion post laparoscopic ureterolithotomy.

*Serum creatinine will be repeated on post-op DAY 3 for both the groups

Following parameters to be compared for both the groups:

1.     Operative time

   -Stenting time separately (in stented group)

2.     Nature & Quantity of drain output

3.     Duration of Drain removal

4.     Duration of hospital stay

5.     Post-operative complications (up to 3 months)

Method of follow up: All patients are to be followed up as per advised at the time of discharge till a period of 3 months.

STATISTICAL ANALYSIS:

1. Data collected will be entered and analyzed using IBM SPSS 22(IBM corporation, Armonk, NY, USA)
2. Qualitative variables will be expressed as percentages.
3. Quantitative variable will be expressed as MEAN +/- STANDARD DEVIATION (for normally distributed data) or MEDIAN + IQR for non normally distributed data.
4. For qualitative variables χ² test of independence association & FISCHER’S test will be used
5. For quantitative data variable MANWHITNEY-U TEST, T-test & ANOVA test wherever applicable
6. P<0.05 will be considered significant

ETHICAL  CONSIDERATION

THE STUDY WILL BE UNDERTAKEN AFTER OBTAINING PERMISSION FROM INSTITUTIONAL ETHICAL COMMITTEE AND STANDARD GUIDELINES WILL BE FOLLOWED. INFORMED CONSENT WILL BE TAKEN FROM THE PATIENTS BEFORE RECRUITING THEM FOR STUDIES AFTER EXPLAINING RISK AND BENEFITS IN A LANGUAGE PATIENT WILL COMPLETELY COMPREHEND.

  BIBLIOGRAPHY

  1.     Yallappa S, Amer T, Jones P, Greco F, Tailly T, Somani BK, et al. Natural History of Conservatively Managed Ureteral Stones: Analysis of 6600 Patients. J Endourol. 2018;32(5):371–9.

  2.     Rajendran P, Senthil K. Laparoscopic ureterolithotomy. Oper Atlas Laparosc Reconstr Urol. 2009;20(1):291–300.

  3.     Das J, Rangad G. A new and easy technique of double-J stenting after retroperitoneal laparoscopic ureterolithotomy: A discussion of other techniques. Urol Ann. 2020;12(4):309.

 4.      Liu X, Huang C, Guo Y, Yue Y, Hong J. Comparison of DJ stented, external stented and stent-less procedures for pediatric pyeloplasty: A network meta-analysis [Internet]. Vol. 68, International Journal of Surgery. Elsevier Ltd; 2019 [cited 2020 Oct 14]. p. 126–33. Available from: https://linkinghub.elsevier.com/retrieve/pii/S1743919119301530

 5.      Hammady A, Gamal WM, Zaki M, Hussein M, Abuzeid A. Evaluation of ureteral stent placement after retroperitoneal laparoscopic ureterolithotomy for upper ureteral stone: Randomized controlled study. J Endourol. 2011;25(5):825–30.

 6.      Cavalli AC, Tambara Filho R, Slongo LE, Cavalli RC, Rocha LC de A. The use of double-J catheter decreases complications of retroperitoneoscopic ureterolithotomy. Rev Col Bras Cir [Internet]. 2012;39(2):112–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22664517

 7.      Karami H, Javanmard B, Hasanzadeh-Hadah A, Mazloomfard MM, Lotfi B, Mohamadi R, et al. Is it necessary to place a Double J catheter after laparoscopic ureterolithotomy? A four-year experience. J Endourol. 2012;26(9):1183–6.

 8.      You JH, Kim YG, Kim MK. Should we place Ureteral stents in retroperitoneal Laparoscopic Ureterolithotomy?: Consideration of surgical techniques and complications. Korean J Urol. 2014;55(8):511–4.

 9.      Soltani MH, Shemshaki H. Stented Versus Stentless Laparoscopic Ureterolithotomy: A Systematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech. 2017;27(12):1269–74.

10.     Srivastava A, Dhayal IR, Rai P. Laparoscopic Ureterolithotomy in Children: With and Without Stent - Initial Tertiary Care Center Experience with More Than 1-Year Follow-Up. Eur J Pediatr Surg. 2017;27(2):150–4.

ANNEXURES

     I.         CASE SHEET (STUDY PROFORMA)

1. Name:
2. Age:   
3. Sex:         
4. MRN: 
5. Address with contact number: _______________________________________________________________________________________________________________________________________________________________________________________________________________
6. PRE-OP INVESTIGATION (APPLICABLE):

7.     X-ray KUB Report (POST-OP)

            DJ STENT INSITU:                YES                                                       NO

8.     Operative time:

            Stenting time(stented):

9.     Total quantity of drain output:

10.   Duration of Drain removal:

11.   Hospital stay in days:

12.   Time period from date of surgery till removal of stent:

13.   Complications post operatively:

                                    Within(time span):

PATIENT INFORMATION SHEET

I, Dr. AKRITI as part of my D.N.B thesis, am conducting a study comparing the outcome of laparoscopic ureterolithotomy with and without stent placement.

The purpose of the study is to find out whether putting a stent is superior to stentless surgery.

As part of this study you will be either receiving or not receiving DJ stent while undergoing surgery.

The selection will be random and data will be collected according to predefined parameters for comparison.

 It will be helpful if you can take part in this study to see whether DJ stent insertion helps with quicker recovery , lesser hospital stay and lesser/no post-operative complications.

The superiority of either of the methods has not yet been well established to call one better over the other.

 As part of the study, you are requested to follow up with us till 3 months as advised after discharge.

 By taking part in the study you are helping the society for a greater cause .

 The data collected from you will be kept confidential and will not be revealed to anybody and will not be used for any other purpose except for my research work.

If you need more information regarding the stent or anything related to my study you can contact me or my guide DR. JAYANTA KUMAR DAS and my co-guide DR. GORDON M RANGAD .

                                           PATIENT INFORMATION SHEET

NGA I DR. AKRITI, KUM KA BYNTA JONG KA JINGPULE JONGNGA, NGA LEH KAWEI KA JINGPULE BNIAH KABA PYNIANUJOR IA KA JINGMYNTOI HAPDENG JONG KA LAPAROSCOPIC URETEROLITHOTOMY DA KABA BUH IA U STENT BAD DA KA BA KHLEM BUH IA U STENT.

KA JINGTHMU JONG KANE KA JINGPULE KA LONG BA YN BUH IA U DJ STENT LANE YN NYM BUH HA KA POR BA SUMAR/PUID IAPHI.

KANE KAN IARAP LADA PHI LAH BAN SHIM BINTA HA KANE KA JINGPULE BAN PEIT BNIAH BA DA KA BA BUH IA UNE U DJ STENT, U LAH NE EM BAN IARAP BAN KHLAIN KLOI NA KA JINGSHITOM, NE BAN SAH KHYNDIAT SNGI HA HOSPITAL BAD BAN PYNDUNA IA KI JINGMA BAD JINGSHITOM HADIEN.

KUM KA BYNTA KA JINGPULE, NGA KYRPAD IA PHI BAN WAN PYNI DOKTOR HADUH 3 BNAI KUMBA LAH BATAI HA KA POR BA IOH MIH NA HOSPITAL.

PHI LAH IARAP IA KA IMLANG SAHLANG SHIBUN DA KA BA SHIM BYNTA HA KANE KA JINGPULE BNIAH JONGNGA.

KIEI KIEI KI BA PHI IATHUH IANGI KIN LONG BEIT TANG HAPHI BAD NGIN NYM IATHUH NE PYNBNA HANO HANO.

BAD RUH KANE KADEI TANG KA JINGPULE BNIAH HI, YM DEI NA KA BYNTA KINO KINO KIWEI PAT KI JINGTHMU.

LADA PHI KWAH TIP BNIAH SHUH SHUH SHAPHANG KANE KA JINGPULE JONGNGA , PHI LAH BAN PHONE IA NGA LANE KYLLI IA KI NONGHIKAI JONGNGA , KITA KIDEI I

 DR. JAYANTA DAS BAD I DR. RANGAD.  

                                          INFORMED CONSENT FORM

Subject identification number for this trial:

Title of the project: - STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESS LAPAROSCOPIC URETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL

Name of the principal investigator: DR. AKRITI , Mob no. 9340952563

I have received the information sheet on the above study and have read and/or understood the written information. I have been given the chance to discuss the study and ask questions.

I consent to take part in the study and I am aware that my participation is voluntary. I understand that I may withdraw at any time without this affecting my future care.

I understand that the information collected about me from my participation in this research and sections of any of my medical notes may be looked at by responsible persons (ethics committee members / regulatory authorities).

I give access to these individuals to have access to my records.

 I understand I will receive a copy of the patient information sheet and the informed consent form.

Signature/thumb impression of subject                                                                          Date

Printed name of the subject in capitals

Signature/thumb impression of the legally accepted representative                               Date

KA JIGPYNTIP BAN AI JINGMYNJUR

Serial no.-

KA PHANG JONG KA JING PULE: STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESS LAPAROSCOPIC URETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL

KA KYRTENG JONG KA NONGWAD JINGTIP BA KONGSAN:  DR. AKRITI , 9340952563

NGA LA IOH IAKA LAD BANIAPHYLLIEW JINGMUT BAD BAN TIPKHAM BNIAH HALOR KANE KA PHANG PDENG.

NGA AI IAKA JING MANJUR BAN SHIM BYNTA HAKANE KAJINGWAD BNIAH,NGA SNGEWTHUH BAD NGA SHIM BYNTA DA KA MON BA LAITLIUD BAD NGA LAH BAN KYLLI JINGKYLLI.

NGA SNGEWTHUH BA NGA LAH BAN KYNRAN DIEN HA KANO KANO KA POR KHLIEM KA JINGKTAH IAKA JINGAI JINGSUMAR KABA HADIEN HABUD.

NGA SNGEWTHUH BA KA JINGTIP BALA LUM SHAPHANG JONG NGA HA KANE KA JINGWAD BNIAH BA IA DEI BAD KA JINGAI JINGSUMAR LAH BAN KHMIH DA KI BRIEW KI BA IA DONBYNTA HAKANE KA JINGWAD BNIAH NGA AI LAD IAKINE KI BRIEW BAN KHMIH IAKA JINGTOH BA IA DEI BAD KA JINGAI JINGSUMR IANGA.

NGA SNGEW THUH, BA NGAN SA IOH PDIANG IAKA JINGTHOH BA DON IAKA JINGTIP U/KA NONGPANG BAD IAKA JINGTHOH JINGPYNTIP BAN AI JINGMYNJUR.

JINGSOI----------------------------------------                             JINGSOI--------------------                                                                                         KYRTENG--------------------------------------                            KYRTENG-------------------------    

 (NONGPANG )                                                                        (NONGSAKHI)          

KYRTENG DOKTOR                                                            JINGSOI BAD KA SEAL

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