Objectives of Study
Stapled hemorrhoidopexy has become a popular, safe, day care, standard of care procedure for properly selected cases of symptomatic hemorrhoids. A clean, faeces free rectum is desirable for optimum results. There is no unanimity on the extent and type of ideal rectal preparation. A clean rectum should facilitate operative manoeuvres and minimize any adverse sequel. Oral Biscodyl or lower rectal enema (LRE) can be used to achieve this. We studied the comparative efficacy of Biscodyl, LRE and no rectal preparation in stapled hemorrhoidopexy.
Methods and procedures
Prospective study (July 2005 to May 2009) study on properly evaluated consecutive candidates of stapled hemorrhoidopexy was carried following ethics and informed consent protocol. Patients were randomized into three groups i.e. controlled group (those born between 1 – 10th of a month), study group Biscodyl (born between 11-20th of a month) and study group LRE (born between 21-30th/31st of a month) to be given no rectal preparation or 10 mg oral Biscodyl the night before or preoperative LRE respectively. They were operated following a standard anesthesia, antibiotic, analgesia protocol on a day care ambulatory basis. Per-operative operator comfort on 10 point interval rating system (IRS) (0- no problem, 10 – uncomfortable), need to apply reinforcing hemostatic suture at staple line and operating time were the surgeon reported outcome (SRO) measures. All the patients were advised to report any adverse feelings or events. Postoperative bleeding, fever and clinical evidence of perineal sepsis during a follow up of three weeks were patient reported outcome (PRO) study points.
A total of 137 patients were randomized. The groups were well matched for demographics, co-morbidities and hemorrhoidal grades. No adverse events, postoperative bleeding, fever or sepsis was reported in either of the groups.
|Control||Study Biscodyl||Study LRE|
|Number of Patients(NOP)||51||39||47|
|NOP needing hemostatic sutures||21||4||7|
|Operating Time (Minutes)||40||25-70||26||22-55||31||20-60|
|Operator Comfort IRS Score||7||5-10||0.6||0-3||3||2-7|
Clear rectum facilitated by preoperative preparation facilitates and expedites performance of stapled hemorrhoidopexy without any benefits on clinical or patient reported outcomes. Oral Biscodyl (a night before) is not inferior to rectal enema.
Program Number: P127