Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial
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Seroma is a virtually unavoidable early sequela after TEP hernioplasty. This randomised controlled trial evaluated the outcomes of preperitoneal closed-system suction drainage in laparoscopic totally extraperitoneal (TEP) hernioplasty for inguinal hernia.
Ninety patients aged 18–80 years who presented to our hospital between May 2016 and February 2017 with primary unilateral inguinal hernia were randomised into the preperitoneal drain and no-drain groups. The primary outcome was seroma size on postoperative day 6. Secondary outcomes included clinical seroma formation and seroma size on day 1, day 6, 1 and 7 months postoperatively, length of postoperative stay, pain score, and recurrence.
There was no significant difference in age, sex, co-morbidities, hernia side, mean hernia size, operating time, fixation adjuncts, or postoperative stay. The overall incidence of clinical seroma formation was 25.6% on postoperative day 1, 60.3% on postoperative day 6, 13.2% 1 month and 0% 7 months postoperatively. The mean drain output was 57.9 ml. The drain group had significantly fewer patients with seroma on day 1 (6 vs 14, p = 0.022) and day 6 (17 vs 30, p = 0.000), and a smaller mean seroma size on days 1 and 6 (p = 0.000). Subgroup analysis showed that sac ligation versus reduction, peritoneal perforation, and fixation adjuncts had no significant effects on seroma formation or size. There is a trend of lower early post-operation VAS score and more urinary retention in drain group was observed but not reaching statistical significance. No differences in postoperative pain score or complications were observed at 1 and 7 months’ post operation.
Preperitoneal drainage for 23 h after laparoscopic TEP hernioplasty for inguinal hernia can effectively decrease seroma formation in the early postoperative period, and potentially improving postoperative pain. The benefit is short-term and no significant difference was demonstrated after 1-month post operations. This tradition technique applied to novel operative repair of inguinal hernia is safe and feasible with no significant morbidity demonstrated. Preperitoneal drainage after TEP can be considered as an option to improve patient satisfactions and recovery in selected patient group for maximal benefit, especially for those with prolonged operation which may associate with higher chance of seroma formation.
KeywordsDrain Laparoscopic Inguinal Hernia Seroma
The authors thank ZL; GZ; HZ; JL; JW; JS for assisting with creation of a database and patients care. Expert advice from Prof Anil.Sharma. is greatly acknowledged.
JKMF—Original idea, data analysis, preparation of manuscript, critical revision of manuscript; JL—data collection and follow-up of patients; KC—data collection and follow-up of patients; XX—data collection and follow-up of patients; HKC—critical revision of manuscript; FSYC—original idea, Critical revision of manuscript; KWHC—data collection and follow up of patients; CML—critical revision of manuscript.
No funding was received for conducting this trial.
Compliance of ethical standards
Conflicts of interest
JKMF declare no conflict of interest; JL declare no conflict of interest; KC declare no conflict of interest; XF declare no conflict of interest; XX declare no conflict of interest; HKC declare no conflict of interest; FSYC declare no conflict of interest; KWHC declare no conflict of interest; CML declare no conflict of interest.
All procedures involving human participants were performed in accordance with the ethical standards of our institutional research committee and the study was conducted according to the ethical standards of the Helsinki Declaration of 1975.
Human and animal rights
This article does not contain any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study after detail explanation of possible complications. Patients were then given at least 24 h for consideration of participating in the clinical trial before operation.