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A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery.

Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ - Trials (2014)

Bottom Line: The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery.Between-group comparisons were made using Fisher's exact test.This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.

View Article: PubMed Central - PubMed

Affiliation: Chirurgie Digestive, Hôpital Nord, CERC (Centre d'Enseignement et de Recherche Chirurgical), Aix-Marseille Université, Chemin des Bourrellys, 13915 Marseille, Cedex 20, France. stephane.berdah@ap-hm.fr.

ABSTRACT

Background: Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.

Methods: This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.

Results: Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).

Conclusions: This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.

Trial registration: ClinicalTrials.gov NCT00813397. Registered 19 December 2008.

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Patient disposition. ITT, intent-to-treat.
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Fig1: Patient disposition. ITT, intent-to-treat.

Mentions: The study was carried out between September 2008 and July 2009. Patient disposition is summarized in Figure 1. Of 209 patients randomised to the HA/CMC powder (n = 105) or the no adhesion barrier (n = 104) groups, only one patient in each group discontinued prior to study end (one death in each group). Patient characteristics and medical history were similar (Table 1), except for a lower frequency of patients with concomitant allergic diseases (P = 0.031) and a higher frequency of patients taking concomitant penicillin combinations (significance not tested) in the HA/CMC powder group versus no adhesion barrier. Previous or concomitant immunosuppressive drugs were taken by 7/105 (7%) patients in the HA/CMC powder group and 12/104 (12%) patients in the no adhesion barrier group (P = 0.221), and corticosteroids by 15/105 (14%) and 22/104 (21%) patients, respectively (P = 0.193). Within the year prior to study randomisation (but not within 30 days before surgery), 10/105 (19%) of patients in the HA/CMC powder group and 7/104 (15%) in the no adhesion barrier group had received abdominal or pelvic radiotherapy (P = 0.666), and 9/105 (17%) and 8/104 (17%), respectively, had received chemotherapy (P = 0.958). Intraoperative parameters were comparable between groups (Table 2), although adhesiolysis (P = 0.073) and manual anastomosis (P = 0.034) were performed more frequently in the HA/CMC powder group.Figure 1


A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery.

Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ - Trials (2014)

Patient disposition. ITT, intent-to-treat.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4233044&req=5

Fig1: Patient disposition. ITT, intent-to-treat.
Mentions: The study was carried out between September 2008 and July 2009. Patient disposition is summarized in Figure 1. Of 209 patients randomised to the HA/CMC powder (n = 105) or the no adhesion barrier (n = 104) groups, only one patient in each group discontinued prior to study end (one death in each group). Patient characteristics and medical history were similar (Table 1), except for a lower frequency of patients with concomitant allergic diseases (P = 0.031) and a higher frequency of patients taking concomitant penicillin combinations (significance not tested) in the HA/CMC powder group versus no adhesion barrier. Previous or concomitant immunosuppressive drugs were taken by 7/105 (7%) patients in the HA/CMC powder group and 12/104 (12%) patients in the no adhesion barrier group (P = 0.221), and corticosteroids by 15/105 (14%) and 22/104 (21%) patients, respectively (P = 0.193). Within the year prior to study randomisation (but not within 30 days before surgery), 10/105 (19%) of patients in the HA/CMC powder group and 7/104 (15%) in the no adhesion barrier group had received abdominal or pelvic radiotherapy (P = 0.666), and 9/105 (17%) and 8/104 (17%), respectively, had received chemotherapy (P = 0.958). Intraoperative parameters were comparable between groups (Table 2), although adhesiolysis (P = 0.073) and manual anastomosis (P = 0.034) were performed more frequently in the HA/CMC powder group.Figure 1

Bottom Line: The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery.Between-group comparisons were made using Fisher's exact test.This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.

View Article: PubMed Central - PubMed

Affiliation: Chirurgie Digestive, Hôpital Nord, CERC (Centre d'Enseignement et de Recherche Chirurgical), Aix-Marseille Université, Chemin des Bourrellys, 13915 Marseille, Cedex 20, France. stephane.berdah@ap-hm.fr.

ABSTRACT

Background: Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.

Methods: This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.

Results: Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).

Conclusions: This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.

Trial registration: ClinicalTrials.gov NCT00813397. Registered 19 December 2008.

Show MeSH
Related in: MedlinePlus