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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ahmed Mohamed Abdelaal, MD
- Puhelinnumero: +201118732767
- Sähköposti: drabdelaal90@gmail.com
Opiskelupaikat
-
-
Al-Manial, Cairo, Egypt
-
Cairo, Al-Manial, Cairo, Egypt, Egypti, 11451
- Rekrytointi
- Faculty of medicine, Cairo University
-
Ottaa yhteyttä:
- Ahmed Mohamed Abdelaal, MD
- Puhelinnumero: +201118732767
- Sähköposti: drabdelaal90@gmail.com
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)
Patients will be conducted to 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.
|
|
Active Comparator: Milligan-Morgan Hemorrhoidectomy
Patients will be conducted to 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Post operative pain intensity in both groups
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Operative time
Aikaikkuna: During surgery]
|
Compare time of operation between both procedure
|
During surgery]
|
|
Number of participants with surgical site infection
Aikaikkuna: 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
Aikaikkuna: Within 48 hours postoperatively
|
compare incidence of postoperative urine retention in both groups
|
Within 48 hours postoperatively
|
|
Post operative anal stenosis in both groups
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Mostafa Sedky, MD, Cairo University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- MS-625-2025
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .