| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ctandup@gmail.com].
- 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.
- 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. |