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CTRI Number  CTRI/2021/10/037342 [Registered on: 18/10/2021] Trial Registered Prospectively
Last Modified On: 14/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   omparison of the incidence of Surgical Site Infection in gunsight technique with conventional technique of stoma closure  
Scientific Title of Study   Randomized study to compare the incidence of Surgical Site Infection in gunsight technique with conventional technique of stoma closure  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHERRING TANDUP 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 26 5th floor Nehru Hospital, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  08196991007  
Fax    
Email  ctandup@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  CHERRING TANDUP 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 26 Nehru Hospital, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  08196991007  
Fax    
Email  ctandup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHERRING TANDUP 
Designation  Assistant Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 26 Nehru Hospital, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  08196991007  
Fax    
Email  ctandup@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research 
 
Primary Sponsor  
Name  NA 
Address  n/a 
Type of Sponsor  Other [not announced] 
 
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 Cherring Tandup  Post Graduate Institute of Medical Education and Research  Room No. 26 B Block Nehru Hospital, PGIMER Sector 12
Chandigarh
CHANDIGARH 
08196991007

ctandup@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
iNSTITUTIONAL ETHICS COMMITEE PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (2) ICD-10 Condition: K633||Ulcer of intestine, (3) ICD-10 Condition: K512||Ulcerative (chronic) proctitis, (4) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional closure   will receive conventional skin incision and closure of the wound  
Intervention  Gunsight closure  Will receive gunsight skin incision and closure of the wound 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. All patients listed for elective stoma closure
2. Age ≥ 14 years
3. Giving informed consent
 
 
ExclusionCriteria 
Details  1. Patients requiring laparotomy for stoma reversal
2. Patients having previous bogota closure scar mark
3. Patients having large para-stomal hernia requiring mesh repair
4. Co-existent psychiatric or neurological illness
5. Inability to answer the survey
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
compare the rate of Surgical Site Infection between two groups, one receiving a gunsight skin incision and other conventional linear closure incision for stoma reversal.  Post Operative day 3, day 5, day 7 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary endpoint-
1. Time taken to complete healing
2. Subjective cosmetic outcome
3. Duration of surgery
4. Length of hospital stay
 
Subjective cosmetic outcome at 3 months of follow up 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   18/10/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ctandup@gmail.com].

  6. For how long will this data be available start date provided 27-01-2023 and end date provided 27-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Creation of the temporary intestinal stomas is an integral part of various emergency and elective surgical procedures1. Temporary diverting stoma such as loop ileostomy is commonly used in the colorectal cancer surgery, inflammatory bowel disease (ulcerative colitis) in order to reduce anastomotic complications2. Use of temporary stomas has been proven to be effective in cases of perforation peritonitis presenting with severe sepsis3, 4.

            Stoma reversal (SR) is often considered by many surgeons to be a low morbidity operation. However, SR is associated with anastomotic leak, hernia formation, surgical site infections (SSIs), and nonsurgical complications, such as pneumonia, deep venous thrombosis, and urinary tract infection and a poor cosmetic outcome5,6. Surgical site infection is the most common complication associated with SR, and the reported incidence of SSI varies widely, from 2% to 40%7.

            Various studies have evaluated several factors that may affect SSI rates following SR. In particular, different skin closure techniques have been studied with varying success in decreasing the rate of SSI8. Most studies report that primary closure (PC) is associated with the highest rate of SSI9. Several retrospective studies found that secondary closure (SC), delayed PC, and loose PC (LPC) are superior to primary closure10,11. Recently, various studies are being conducted on purse-string closure technique and it has been found effective in decreasing the rate of SSI as compared to other described techniques2, 11-13. Lim et al14 described the gunsight technique for stoma reversal and primary study suggested that the gunsight (GS) skin closure technique allows adequate surgical exposure, facilitates the creation of a small central hole, and provides a pleasant cosmetic scar. A multicenter, prospective, and randomized study was done by Han JG  and colleagues15 where they compared gunsight closure with the purse-string closure technique for SR and concluded that both the techniques are effective procedures, with a low incidence of wound infection but gunsight technique had the advantage of a shorter wound healing time and higher levels of patient satisfaction with regard to healing time. Another retrospective study on gunsight closure technique showed that GS technique can significantly decrease the rate of SSI when compared with the PC technique16. In this study we intent to compare the incidence of SSI in both the gunsight closure technique and the primary closure technique of stoma reversal.

 
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