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CTRI Number  CTRI/2021/02/031023 [Registered on: 04/02/2021] Trial Registered Prospectively
Last Modified On: 04/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two laparoscopic surgeries for uterine or vault prolapse correction 
Scientific Title of Study   Comparison of Laparoscopic Pectopexy with the standard Laparoscopic Sacropexy for Apical Prolapse: An exploratory randomized controlled trial. 
Trial Acronym  Laparoscopic pectopexy 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavita Khoiwal 
Designation  Assistant Professor 
Affiliation  AIIMS RISHIKESH 
Address  Department of Obstetrics and Gynecology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9690396908  
Fax    
Email  kavita.kh27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavita Khoiwal 
Designation  Assistant Professor 
Affiliation  AIIMS RISHIKESH 
Address  Department of Obstetrics and Gynecology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9690396908  
Fax    
Email  kavita.kh27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanhu Charan Dash 
Designation  Junior Resident 
Affiliation  AIIMS RISHIKESH 
Address  Department of Obstetrics and Gynecology AIIMS Rishikesh Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9439653374  
Fax    
Email  kanhu101251@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Rishikesh 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Rishikesh 
Address  Virbhadra marg, Rishikesh,Uttarakhand,India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavita Khoiwal  All India Institute Of Medical Sciences Rishikesh  Room Number-016103, Level 6,Department Of Obstetrics and Gynecology, Academic Block
Dehradun
UTTARANCHAL 		 9690396908

kavita.kh27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N813||Complete uterovaginal prolapse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  laparoscopic pectopexy  compare laparoscopic pectopexy with the standard laparoscopic sacropexy in women with symptomatic apical prolapse (POP-Q stage II). 
Comparator Agent  laparoscopic sacropexy  compare laparoscopic pectopexy with the standard laparoscopic sacropexy in women with symptomatic apical prolapse (POP-Q stage II) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1. Women with symptomatic apical prolapse (uterovaginal prolapse or vaginal vault prolapse) of stage 2 or greater according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
2. Women who agree to participate in the trial and to comply with the protocol and give their written consent for the same.
3. Patients who are able to communicate by telephone and answer questions.
4. Adequate cardio respiratory, renal and liver functions and who will be fit to undergo surgery.
 
 
ExclusionCriteria 
Details  Prior surgeries for vaginal prolapse correction
2. Active pelvic inflammatory disease
3. Current pregnancy
4. Any contraindications against one of the surgical methods applied in the study, hence making the randomization impossible (e.g. previously identified or strongly suspected massive adhesions between sigmoid colon and presacral peritoneum.
5. History of premalignant or malignant diseases of uterus, cervix or adnexa
6. Any contraindication for laparoscopic surgery
7. Patient unfit for anaesthesia
8. Patient not willing to comply with the protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Average placement of mesh time   1 year 6 month  
 
Secondary Outcome  
Outcome  TimePoints 
operation time, blood loss, occurrence of major complications.
Hemoglobin decline, Pain (VAS score), duration of hospital stay, onset of bowel movements, episodes of constipation, urinary retention or urgency, de novo urinary incontinence (urge or stress urinary incontinence), urinary tract infections, occurrence of de novo anterior and lateral defect, de novo cystocele, de novo rectocele, dyspareunia, mesh erosion, relapse of apical prolapse and satisfaction rate.
 		 1 year 6 month 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will publish once trial completed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Sacrocolpopexy is considered to be the gold standard surgical treatment of vaginal vault prolapse. Abdominal and laparoscopic approaches to sacrocolpopexy are feasible, but the laparoscopic sacrocolpopexy obviates the need of large abdominal incision, and associated with minimal tissue handling, less blood loss, less postoperative morbidity, less pain, shorter hospital stay. Laparoscopic sacrocolpopexy is preferred than open sacrocolpopexy for apical vaginal defect in hands of expertise.

The laparoscopic pectopexy is a newer alternative of sacropexy. It was first described in 2010 by Noe KG et al , especially for obese women. In laparoscopic pectopexy, mesh is fixed at bilateral ilio-pectineal ligament and the apex of vaginal vault or anterior cervical wall. The mess follows the natural anatomical structure (round and broad ligament) to maintain the physiological axis without crossing ureter or bowel; therefore, pelvic outlet does not shrink and it fixes the weakness using lateral parts of the ilio-pectineal ligaments on both sides. In addition, the hypogastric vessels are also a safe distance from any danger.

The aim of the present study is to compare laparoscopic pectopexy with the standard laparoscopic sacropexy in women with symptomatic apical prolapse (POP-Q >stage II).


 
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