Randomized Controlled Trial to Compare Stapled Hemorroidopexy Plus Ligation Anopexy With Stapled Hemorroidepexy for Managing Grade III and IV Hemorroidal Disease.

BACKGROUND: Despite the benefits of the Stapled hemorrhoidopexy in the short term, management of prolapsing hemorrhoids, the long-term results are still insufficient, regarding recurrent prolapse and patient satisfaction so in our current study we add ligation anopexy to stapled hemorroidopexy.

OBJECTIVE: Valuation of adding ligation anopexy to stapled hemorroidopexy in improving short and long-term results in the treatment of grade III-IV hemorrhoids.

DATA SOURCES: Between January 2018 and January 2020 we recruited 124 patients with grade III-IV hemorrhoids, at Alexandria main university hospital.

STUDY SELECTION: Randomized controlled trial.

INTERVENTIONS: One hundred twenty-four patients were blindly randomized into two equal groups, stapled hemorrhoidopexy (group I) and stapled hemorrhoidopexy plus ligation anopexy (group II).

MAIN OUTCOME MEASURES: Recurrence of hemorrhoids and patient satisfaction after a follow-up period of at least two years.

RESULTS: The average operating time was noticeably less in stapled hemorroidopexy group. Meanwhile, postoperative pain, analgesia requirement, hemorrhoids symptoms score, return to work, complications rate, and quality of life 1 month after surgery were similar. Following a mean follow-up of 36 months (interval, 24-47), group I, 10 patients (16%) complained of recurrent external swelling and/or prolapse compared to 3 patients (5%) in group II (p = 0.0368) requiring redo surgery. No redo-surgery was required in group II, furthermore, long-term patient satisfaction was significantly better in group II.

LIMITATIONS: Longer follow-up needed and single-center experience.

CONCLUSIONS: Stapled hemorroidopexy compared to stapled hemorroidopexy plus ligation anopexy were similar at short-term results as regard complications rate, hemorrhoids symptoms score, return to work, and quality of life. Long-term results were significantly better as regard recurrence of external swelling and/or prolapse and patient satisfaction after stapled hemorroidopexy plus ligation anopexy. See Video Abstract.

TRIAL REGISTRATION NUMBER: Pan African Clinical Trials Registry identifier PACTR20180100293130.