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SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease

2026년 5월 16일 업데이트: Ahmed Mohamed Abdelaal, Cairo University

Early Outcomes of Skin-Sparing Hemorrhoidectomy and PExy (SHAPE) Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease: A Randomized Controlled Trial

This study will be conducted at the General Surgery Department, Kasr Al-Ainy Teaching Hospital, Cairo University, on patients presenting with third- and fourth-degree hemorrhoids. Adult patients older than 18 years who fulfill the inclusion criteria and provide informed consent will be enrolled. Patients with inflammatory bowel disease, anal stenosis, colorectal malignancy, or fecal incontinence will be excluded.

All patients will undergo detailed preoperative assessment including medical and surgical history, evaluation of anal symptoms, local anorectal examination, digital rectal examination, and routine laboratory investigations.

Participants will be randomized into two groups: Group A will undergo Skin-Sparing Hemorrhoidectomy and PExy (SHAPE), while Group B will undergo conventional Milligan-Morgan hemorrhoidectomy.

Postoperatively, oral fluids will be allowed after 2 hours and normal diet resumed as tolerated. Patients will be discharged on the first postoperative day unless otherwise indicated. Follow-up visits will assess postoperative pain, complications, and surgical outcome

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This randomized controlled study will be conducted at the General Surgery Department, Kasr Al-Ainy Teaching Hospital, Cairo University, on patients presenting with third- and fourth-degree hemorrhoids. Adult patients older than 18 years who fulfill the inclusion criteria and provide informed consent will be included in the study. Patients with inflammatory bowel disease, anal stenosis, colorectal malignancy, or pre-existing fecal incontinence will be excluded.

Patients attending the outpatient clinic with symptoms suggestive of hemorrhoidal disease will be assessed according to the study criteria. After explaining the purpose and nature of the study, informed written consent will be obtained. All patients will undergo detailed preoperative evaluation including complete medical and surgical history, assessment of symptoms such as pain, bleeding, prolapse, discharge, and pruritus ani, in addition to local anorectal examination and digital rectal examination. Routine preoperative laboratory investigations will be performed for all patients, while colonoscopy will be requested in selected cases to exclude colorectal malignancy or other causes of lower gastrointestinal bleeding.

Participants will be randomly allocated into two groups. Group A will undergo Skin-Sparing Hemorrhoidectomy and PExy (SHAPE), which involves selective excision of hemorrhoidal tissue above the dentate line with preservation of anoderm followed by mucopexy using Vicryl sutures. Group B will undergo conventional Milligan-Morgan hemorrhoidectomy with excision of hemorrhoidal tissue, pedicle ligation, and preservation of skin bridges.

Postoperatively, oral fluids will be initiated after 2 hours and regular diet resumed as tolerated. Most patients will be discharged on the first postoperative day unless otherwise indicated. Patients will be reviewed twice weekly during the first postoperative week, weekly for the first month, and monthly thereafter to assess pain using the Visual Analog Scale (VAS), wound healing, postoperative complications, and surgical outcomes.

연구 유형

중재적

등록 (추정된)

68

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

  • 이집트
    • Al-Manial, Cairo, Egypt
      • Cairo, Al-Manial, Cairo, Egypt, 이집트, 11451
        • 모병
        • Faculty of medicine, Cairo University
        • 연락하다:

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:

  • All patients with third- and fourth-degree piles, and their age greater than 18 years old

Exclusion Criteria:

  • Patients with inflammatory bowel disease.
  • Patients with anal stenosis
  • Patients with colorectal malignancy
  • Patient with fecal incontinence

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: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)
Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)
절차: Skin Sparing Hemorrhoidectomy and PExy (SHAPE)
The procedure involves the selective excision of the hemorrhoidal columns ensuring that the dissection will be initiated cranial to the dentate line, with a preserved margin of at least 5 mm from it. This approach aims to maintain anoderm integrity while effectively addressing both internal and external hemorrhoidal components Following the line of dissection, a mucopexy will be performed using Vicryl 2/0 (polyglactin 910) . This step not only ensured adequate fixation of the prolapsed mucosa but also facilitated a lifting and smoothing effect on the external cutaneous component.
활성 비교기: Milligan-Morgan Hemorrhoidectomy
Patients will be conducted to Milligan-Morgan Hemorrhoidectomy
절차: Milligan-Morgan Hemorrhoidectomy
A V-shaped incision is made using a cutting cautery device in the skin surrounding the base of the hemorrhoid. Then dissection in the submucousal plane will be done by cautery to strip the hemorrhoid from its bed. The dissection will be continued in the cranial direction up to the pedicle. The pedicle will be then double ligated with a 2/0 vicryl suture, and the distal part of the hemorrhoid will be excised. The same steps will be carried out regarding the other hemorrhoids ( if present), leaving a skin bridge at least one centimeter between them to avoid anal stenosis. The wound will be left open, and an external pack of gauze will be applied.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Post operative pain intensity in both groups
기간: At day 1, day 7 and day 30 postoperatively
Assessment of Post operative pain in both groups. (Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}).
At day 1, day 7 and day 30 postoperatively

2차 결과 측정

결과 측정
측정값 설명
기간
Operative time
기간: During surgery]
Compare time of operation between both procedure
During surgery]
Number of participants with surgical site infection
기간: Up to 3 months postoperatively
compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)
Up to 3 months postoperatively
Post operative urine retention
기간: Within 48 hours postoperatively
compare incidence of postoperative urine retention in both groups
Within 48 hours postoperatively
Post operative anal stenosis in both groups
기간: Up to 3 months postoperatively

Postoperative anal stenosis will be assessed by digital rectal examination and graded clinically as follows:

Mild: anal canal admits a well lubricated index finger. Moderate: Forceful dilatation required to admit a well lubricated index finger. Severe: Little finger cannot be admitted without forceful dilatation
Up to 3 months postoperatively
Recurrence of hemorrhoids in Both groups
기간: Up to 3 months postoperatively
Recurrence of hemorrhoids was defined as the reappearance of hemorrhoidal symptoms (bleeding, pain, or prolapse) and/or clinical evidence of hemorrhoids after initial postoperative resolution during the follow-up period
Up to 3 months postoperatively
Time to return to normal activity
기간: Up to 3 months postoperatively
Compare Time to return to normal activity in both groups
Up to 3 months postoperatively
Number of participants with Postoperative bleeding
기간: Up to 3 months postoperatively
Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).
Up to 3 months postoperatively

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Cairo University

수사관

  • 연구 책임자: Mostafa Sedky, MD, Cairo University

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 (추정된)

2026년 5월 24일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2026년 5월 12일

QC 기준을 충족하는 최초 제출

2026년 5월 16일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 16일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • MS-625-2025

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants

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. .

구독하다