SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease
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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ahmed Mohamed Abdelaal, MD
- 電話番号：+201118732767
- メール：drabdelaal90@gmail.com
研究場所
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Al-Manial, Cairo, Egypt
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Cairo、Al-Manial, Cairo, Egypt、エジプト、11451
- 募集
- Faculty of medicine, Cairo University
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コンタクト：
- Ahmed Mohamed Abdelaal, MD
- 電話番号：+201118732767
- メール：drabdelaal90@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)
Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)
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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.
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アクティブコンパレータ：Milligan-Morgan Hemorrhoidectomy
Patients will be conducted to Milligan-Morgan Hemorrhoidectomy
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Post operative pain intensity in both groups
時間枠：At day 1, day 7 and day 30 postoperatively
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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}).
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At day 1, day 7 and day 30 postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Operative time
時間枠：During surgery]
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Compare time of operation between both procedure
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During surgery]
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Number of participants with surgical site infection
時間枠：Up to 3 months postoperatively
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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.)
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Up to 3 months postoperatively
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Post operative urine retention
時間枠：Within 48 hours postoperatively
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compare incidence of postoperative urine retention in both groups
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Within 48 hours postoperatively
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Post operative anal stenosis in both groups
時間枠：Up to 3 months postoperatively
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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
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Recurrence of hemorrhoids in Both groups
時間枠：Up to 3 months postoperatively
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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
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Up to 3 months postoperatively
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Time to return to normal activity
時間枠：Up to 3 months postoperatively
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Compare Time to return to normal activity in both groups
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Up to 3 months postoperatively
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Number of participants with Postoperative bleeding
時間枠：Up to 3 months postoperatively
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Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).
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Up to 3 months postoperatively
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Mostafa Sedky, MD、Cairo University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MS-625-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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