Health TrialsbyHealthPanel

SHAPE Versus Milligan-Morgan Hemorrhoidectomy for Hemorrhoidal Disease

ConditionHemorrhoid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients with third- and fourth-degree piles, and their age greater than 18 years old

Disqualifiers

Patients with inflammatory bowel disease.

Patients with anal stenosis

Patients with colorectal malignancy

Patient with fecal incontinence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Skin Sparing Hemorrhoidectomy and PExy (SHAPE)

    Procedure/Surgery

    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.

  • Milligan-Morgan Hemorrhoidectomy

    Procedure/Surgery

    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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Skin-Sparing Hemorrhoidectomy and PExy (SHAPE)Experimental treatment 1 intervention
Group B: Milligan-Morgan HemorrhoidectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Operative time

Compare time of operation between both procedure

Time frame
During surgery]
2

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
3

Post operative urine retention

compare incidence of postoperative urine retention in both groups

Time frame
Within 48 hours postoperatively
4

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

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov
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