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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ahmed Mohamed Abdelaal, MD
- Numer telefonu: +201118732767
- E-mail: drabdelaal90@gmail.com
Lokalizacje studiów
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Al-Manial, Cairo, Egypt
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Cairo, Al-Manial, Cairo, Egypt, Egipt, 11451
- Rekrutacyjny
- Faculty of medicine, Cairo University
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Kontakt:
- Ahmed Mohamed Abdelaal, MD
- Numer telefonu: +201118732767
- E-mail: drabdelaal90@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Post operative pain intensity in both groups
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Operative time
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Mostafa Sedky, MD, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MS-625-2025
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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