Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transanal Haemorrhoidal Dearterialisation Versus Stapler Haemorrhoidopexy

NCT01615575

Haemorrhoids

COMPLETED NA

Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids

NCT00841620

Hemorrhoids

COMPLETED PHASE4

Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

NCT01306877

Hemorrhoids

COMPLETED NA

Traditional Ferguson Hemorrhoidectomy vs Stapled Hemorrhoidopexy

NCT05959577

Haemorrhoid

RECRUITING NA

Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone

NCT02372981

Third Degree Hemorrhoids

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. However, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed.

The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. This should result in reduction of the postoperative pain and subsequently should improve the recovery time. Further potential advantages of the technique should include a more physiological approach to the treatment of the disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhoids

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stapled Anopexy

Circular stapled anopexy

Group Type EXPERIMENTAL

Circular stapled anopexy

Intervention Type PROCEDURE

Patients receiving stapled anopexy to treat haemorrhoids

Conventional Haemorrhoidectomy

Closed diathermy haemorrhoidectomy

Group Type ACTIVE_COMPARATOR

Closed diathermy haemorrhoidectomy

Intervention Type PROCEDURE

Conventional haemorrhoidectomy as described by Ferguson method

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Circular stapled anopexy

Patients receiving stapled anopexy to treat haemorrhoids

Intervention Type PROCEDURE

Closed diathermy haemorrhoidectomy

Conventional haemorrhoidectomy as described by Ferguson method

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult human subjects (age \>=16 years) with symptomatic haemorrhoids (Primary or recurrent)
* symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment

Exclusion Criteria

* concurrent untreated or recurrent colorectal cancer
* Active inflammatory bowel disease
* Previous major anorectal surgery
* On anticoagulant medications
* Non-consenting patients
* Unwilling for randomisation

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No