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Low-Residue Diet Versus Rectal Enema Before Laparoscopic Surgery for Endometrial Cancer

2026년 7월 16일 업데이트: Mahmut Yassa

Low-Residue Diet Versus Rectal Enema Before Laparoscopic Endometrial Cancer Surgery: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to compare a standardized 3-day bowel preparation protocol with a rectal enema before laparoscopic surgery for endometrial cancer. The study will evaluate whether the dietary bowel preparation protocol can be used instead of a rectal enema while maintaining an adequate surgical view during surgery.

The main questions it aims to answer are:

  • Can the dietary bowel preparation protocol provide surgical exposure comparable to a rectal enema?
  • Can the dietary bowel preparation protocol reduce the minimum Trendelenburg position and pneumoperitoneum pressure required to obtain an adequate surgical view?
  • Does either bowel preparation method cause more discomfort or side effects before surgery?

Researchers will compare a standardized 3-day bowel preparation protocol with a rectal enema before surgery.

Participants will:

  • Be randomly assigned to receive either a standardized 3-day bowel preparation protocol or a rectal enema before surgery.
  • Undergo standard laparoscopic surgery for endometrial cancer.
  • Have surgical exposure, the minimum Trendelenburg position, the minimum pneumoperitoneum pressure, operative outcomes, postoperative recovery, and bowel preparation-related symptoms and discomfort assessed as part of routine clinical care.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Adequate bowel preparation is important for achieving optimal surgical exposure during laparoscopic surgery for endometrial cancer. Inadequate bowel preparation may impair visualization of the operative field, requiring steeper Trendelenburg positioning and higher pneumoperitoneum pressures, which may increase the physiological burden of surgery and affect operative performance.

Mechanical bowel preparation with rectal enema is commonly used before gynecologic surgery, although its routine use remains controversial because evidence supporting its clinical benefit is limited. A standardized 3-day bowel preparation protocol may improve patient tolerance while maintaining adequate surgical conditions. However, prospective randomized studies comparing these two approaches specifically in laparoscopic endometrial cancer surgery remain limited.

This prospective randomized controlled trial will compare a standardized 3-day bowel preparation protocol with a preoperative rectal enema before laparoscopic surgery for endometrial cancer. The primary objective is to determine whether the dietary bowel preparation protocol can provide surgical conditions comparable to those achieved with rectal enema.

In addition to subjective assessment of surgical exposure, the study will evaluate objective intraoperative parameters, including the minimum Trendelenburg position and the minimum pneumoperitoneum pressure required to maintain an adequate surgical view. Operative outcomes, postoperative recovery, patient tolerance of the bowel preparation methods, and bowel preparation-related symptoms will also be evaluated.

The findings of this study may help optimize preoperative bowel preparation strategies, reduce unnecessary patient burden, and support evidence-based perioperative care for patients undergoing laparoscopic surgery for endometrial cancer.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 터키 (Türkiye)
      • Istanbul, 터키 (Türkiye)
        • 모병
        • Başakşehir Çam and Sakura City Hospital
        • 연락하다:
        • 부수사관:
          • Bora Taşpınar, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Female participants aged 18 to 90 years.
  • Scheduled to undergo elective laparoscopic surgery for endometrial cancer.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Planned open (abdominal) surgery.
  • Known allergy or contraindication to sodium phosphate rectal enema.
  • Age over 90 years.
  • Refusal or inability to provide written informed consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Low-Residue Diet
Participants will follow a standardized 3-day bowel preparation protocol before surgery. The protocol includes a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery
행동: Low-Residue Diet
Participants will follow a standardized 3-day bowel preparation protocol consisting of a low-residue diet on day 3 before surgery, a soft or pureed diet on day 2, and a clear liquid diet on the day before surgery, with adequate hydration throughout the preparation period.
활성 비교기: Rectal Enema
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the institutional bowel preparation protocol
의약품: Sodium Phosphate Rectal Enema
Participants will receive a single sodium phosphate rectal enema approximately 12 hours before surgery according to the manufacturer's instructions and the institutional bowel preparation protocol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Intraoperative Visual Index Score
기간: Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Surgical exposure will be assessed intraoperatively using the Visual Index score after establishment of pneumoperitoneum and placement of the camera trocar and one lateral ancillary trocar. The score ranges from 0 to 2, where 0 indicates inadequate visualization despite bowel retraction with one grasper, 1 indicates adequate visualization requiring bowel retraction with one grasper, and 2 indicates adequate visualization without bowel retraction. Higher scores indicate better surgical exposure.
Intraoperatively, after pneumoperitoneum establishment and placement of the camera trocar and one lateral ancillary trocar
Minimum Trendelenburg Position Required for Adequate Surgical Exposure
기간: Intraoperatively
The minimum Trendelenburg angle (degrees) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Intraoperatively
Minimum Pneumoperitoneum Pressure Required for Adequate Surgical Exposure
기간: Intraoperatively
The minimum pneumoperitoneum pressure (mmHg) required to achieve adequate visualization of the pelvis will be recorded intraoperatively using the predefined assessment protocol.
Intraoperatively

2차 결과 측정

결과 측정
측정값 설명
기간
Operative Time
기간: During surgery
Total operative time measured from skin incision to skin closure, recorded in minutes.
During surgery
Length of Hospital Stay
기간: At hospital discharge, assessed up to 30 days after surgery
Length of postoperative hospital stay, measured in days from surgery until hospital discharge.
At hospital discharge, assessed up to 30 days after surgery
Time to First Flatus
기간: From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Time from completion of surgery to the first documented passage of flatus, measured in hours. The occurrence and timing of first flatus will be assessed during daily postoperative visits until the event occurs or until hospital discharge.
From completion of surgery until the first documented passage of flatus, assessed up to 7 postoperative days
Patient Tolerance of Bowel Preparation
기간: From preoperative bowel preparation until postoperative day 1
Patient tolerance will be assessed using completion of the assigned bowel preparation protocol, willingness to repeat the same preparation method in a future surgery, postoperative pain score, and bowel preparation-related symptoms. Symptoms will include nausea, overall discomfort, headache, insomnia, thirst, abdominal cramps, weakness, and fatigue, each assessed using a 0-10 numeric rating scale, where 0 indicates no symptom and 10 indicates the worst possible symptom.
From preoperative bowel preparation until postoperative day 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Mahmut Yassa

수사관

  • 수석 연구원: MAHMUT YASSA, MD, Başakşehir Çam & Sakura City Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 15일

기본 완료 (추정된)

2028년 1월 15일

연구 완료 (추정된)

2028년 3월 1일

연구 등록 날짜

최초 제출

2026년 7월 6일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 16일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ENDO-DIET-RCT-2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.

IPD 공유 기간

Beginning 6 months after publication of the primary study results and ending 3 years after publication.

IPD 공유 액세스 기준

Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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