- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07573423
Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal.
Comparison of Efficacy Between Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal. A Randomized Control Trial.
This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs.
In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges.
All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time.
The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.
연구 개요
상태
상세 설명
Loop ileostomy reversal is a commonly performed surgical procedure; however, it is associated with a considerable risk of postoperative complications, particularly surgical site infection (SSI). Reported SSI rates after stoma closure range from 4% to over 20%, making it one of the most frequent causes of postoperative morbidity. The development of SSI not only delays wound healing but also contributes to prolonged hospital stay, increased healthcare costs, and reduced patient satisfaction.
Multiple techniques for skin closure following ileostomy reversal have been described, with conventional linear closure and purse-string closure being the most widely practiced. Linear closure involves primary approximation of the wound edges, resulting in complete closure of the skin. In contrast, the purse-string technique leaves a small central opening that allows continuous drainage of wound exudate, which may reduce bacterial colonization and lower the risk of infection.
Previous studies have suggested that purse-string closure may be associated with lower SSI rates and improved cosmetic outcomes compared to linear closure. However, linear closure remains widely used due to its technical simplicity and shorter operative time. Despite available evidence, there is still variability in clinical practice, and further high-quality randomized controlled trials are needed to establish the optimal technique.
This randomized controlled trial was conducted at the Department of General Surgery, MTI-Hayatabad Medical Complex, Peshawar. A total of 252 patients meeting the inclusion criteria were enrolled and randomly allocated into two groups: linear skin closure (Group A) and purse-string skin closure (Group B). Block randomization was used to ensure balanced group allocation.
All patients underwent ileostomy reversal according to standardized surgical protocols. Preoperative optimization, including management of comorbid conditions such as diabetes mellitus and hypertension, was performed as per institutional guidelines. Postoperatively, patients were monitored during their hospital stay and followed up for 30 days to assess outcomes.
The primary outcome of the study was the frequency of surgical site infection within 30 days of surgery. Secondary outcomes included length of hospital stay and duration of surgery. Data were collected using a structured proforma and analyzed using appropriate statistical methods.
The aim of this study is to provide evidence on the comparative effectiveness of purse-string versus linear skin closure techniques in reducing postoperative complications following ileostomy reversal. The results are expected to support evidence-based surgical practice and improve patient outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
KPK
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Peshawar, KPK, 파키스탄, 25000
- Hayatabad Medical Complex
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 20 to 70 years
- Both male and female patients
- Patients undergoing elective loop ileostomy reversal
- American Society of Anesthesiologists (ASA) physical status I-II
- Patients who provide informed consent
Exclusion Criteria:
- Patients with active stoma site infection (e.g., fever with total leukocyte count >11,000/mm³)
- Patients not planned for ileostomy reversal
- Patients with severe comorbid conditions (ASA III or above)
- Patients unwilling to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Linear Skin Closure
Participants undergoing loop ileostomy reversal receive conventional linear skin closure with primary approximation of wound edges.
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Closure of the ileostomy reversal wound using purse-string suturing technique, leaving a central gap for drainage to reduce infection risk.
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활성 비교기: Purse-String Skin Closure
Participants undergoing loop ileostomy reversal receive purse-string skin closure, leaving a small central opening to allow drainage.
|
Closure of the ileostomy reversal wound using conventional linear suturing with complete approximation of skin edges.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Surgical Site Infections Rate
기간: Within 30 days after surgery
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Proportion of participants who develop surgical site infection at the ileostomy reversal wound site, assessed using standard clinical criteria (redness, discharge, swelling, or pus).
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Within 30 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of Hospital Stay
기간: From surgery until hospital discharge (up to 7 days after surgery)
|
Duration of hospital stay measured in days from the date of surgery to discharge.
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From surgery until hospital discharge (up to 7 days after surgery)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Ameer A, Mirza MB, Talat N. The Outcome of Purse-string Versus Conventional Wound Closure Techniques in Patients Undergoing Stoma Reversal: A Randomized Controlled Trial. J Pediatr Surg. 2024 Jun;59(6):1186-1189. doi: 10.1016/j.jpedsurg.2023.10.062. Epub 2023 Oct 30.
- O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.
- Aga E, Keinan-Boker L, Eithan A, Mais T, Rabinovich A, Nassar F. Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond). 2015;47(11):761-7. doi: 10.3109/23744235.2015.1055587. Epub 2015 Jun 26.
- Nota SP, Braun Y, Ring D, Schwab JH. Incidence of surgical site infection after spine surgery: what is the impact of the definition of infection? Clin Orthop Relat Res. 2015 May;473(5):1612-9. doi: 10.1007/s11999-014-3933-y.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HMC-QAD-RCT-3
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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