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SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease

16. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

68

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Egypt
    • Al-Manial, Cairo, Egypt
      • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
        • Rekruttering
        • Faculty of medicine, Cairo University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)
Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)
Fremgangsmåte: 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.
Aktiv komparator: Milligan-Morgan Hemorrhoidectomy
Patients will be conducted to Milligan-Morgan Hemorrhoidectomy
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Post operative pain intensity in both groups
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Operative time
Tidsramme: During surgery]
Compare time of operation between both procedure
During surgery]
Number of participants with surgical site infection
Tidsramme: 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
Tidsramme: Within 48 hours postoperatively
compare incidence of postoperative urine retention in both groups
Within 48 hours postoperatively
Post operative anal stenosis in both groups
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Etterforskere

  • Studieleder: Mostafa Sedky, MD, Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

24. mai 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

12. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MS-625-2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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