An interventional study of Skin Sparing Hemorrhoidectomy and PExy (SHAPE) and Milligan-Morgan Hemorrhoidectomy in Hemorrhoid, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 68 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be conducted to skin sparing hemorrhoidectomy and PExy (SHAPE)
Procedure: Skin Sparing Hemorrhoidectomy and PExy (SHAPE)
Patients will be conducted to Milligan-Morgan Hemorrhoidectomy
Procedure: Milligan-Morgan Hemorrhoidectomy
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.
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.
Post operative pain intensity in both groups
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}).
Time frame: At day 1, day 7 and day 30 postoperatively
Operative time
Compare time of operation between both procedure
Time frame: During surgery]
Number of participants with surgical site infection
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.)
Time frame: Up to 3 months postoperatively
Post operative urine retention
compare incidence of postoperative urine retention in both groups
Time frame: Within 48 hours postoperatively
Post operative anal stenosis in both groups
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
Time frame: Up to 3 months postoperatively
Recurrence of hemorrhoids in Both groups
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
Time frame: Up to 3 months postoperatively
Time to return to normal activity
Compare Time to return to normal activity in both groups
Time frame: Up to 3 months postoperatively
Number of participants with Postoperative bleeding
Postoperative Bleeding will be assessed clinically and categorized as mild (self-limited), moderate (requiring medical treatment), or severe (requiring surgical intervention or blood transfusion).
Time frame: Up to 3 months postoperatively
Plan to share: No — 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
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Jan 2027, 7 months later.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 7 months is below that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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