Reduction of postoperative adhesions by N,O-carboxymethylchitosan

A pilot study

Michael Peter Diamond, Anthony Luciano, D. Alan Johns, Randall Dunn, Phillip Young, Eric Bieber

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Objective: To examine the logistics, safety, and efficacy of N,O-carboxymethylchitosan (NOCC) in reducing adhesions in women. Design: Multicenter, prospective, randomized, reviewer-blinded clinical trial. Setting: Gynecologic practices. Patient(s): Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis. Intervention(s): Adhesion reduction by administration of NOCC vs. Ringer's lactate at the conclusion of the initial surgical procedure, as assessed at second-look laparoscopy. The NOCC was applied as 200 mL of a 1% NOCC gel that was tamped in place, followed by 100 mL of 2% NOCC solution. Efficacy was assessed by covariate analysis. Main Outcome Measure(s): Safety and postoperative adhesion formation. Result(s): Groups did not differ in age, ethnicity distribution, height, weight, or body mass index. No deaths or serious adverse events were attributable to NOCC, and no adverse events were definitively or probably related to NOCC administration. Adhesions recurred at 61% of sites in controls and 38% of sites in NOCC recipients. De novo grade 1a and 1b adhesions tended to occur more commonly in controls than NOCC recipients. Adhesion extent and severity at second look were also less in NOCC recipients. Conclusion(s): Intraperitoneal use of NOCC gel and solution appears to be safe. Despite the small sample, strong trends were identified for reduction of occurrence, extent, and severity of adhesion recurrence and de novo adhesion formation.

Original languageEnglish (US)
Pages (from-to)631-636
Number of pages6
JournalFertility and Sterility
Volume80
Issue number3
DOIs
StatePublished - Sep 1 2003
Externally publishedYes

Fingerprint

Safety
O-carboxymethylchitosan
Gels
Age Distribution
Laparoscopy
Body Mass Index
Outcome Assessment (Health Care)
Clinical Trials
Weights and Measures
Recurrence
Ringer's lactate

Keywords

  • Adhesions
  • Laparoscopy
  • N,O-carboxymethylchitosan

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Reduction of postoperative adhesions by N,O-carboxymethylchitosan : A pilot study. / Diamond, Michael Peter; Luciano, Anthony; Johns, D. Alan; Dunn, Randall; Young, Phillip; Bieber, Eric.

In: Fertility and Sterility, Vol. 80, No. 3, 01.09.2003, p. 631-636.

Research output: Contribution to journalArticle

Diamond, Michael Peter ; Luciano, Anthony ; Johns, D. Alan ; Dunn, Randall ; Young, Phillip ; Bieber, Eric. / Reduction of postoperative adhesions by N,O-carboxymethylchitosan : A pilot study. In: Fertility and Sterility. 2003 ; Vol. 80, No. 3. pp. 631-636.
@article{204c40df8afb466da9ab712cf32d2163,
title = "Reduction of postoperative adhesions by N,O-carboxymethylchitosan: A pilot study",
abstract = "Objective: To examine the logistics, safety, and efficacy of N,O-carboxymethylchitosan (NOCC) in reducing adhesions in women. Design: Multicenter, prospective, randomized, reviewer-blinded clinical trial. Setting: Gynecologic practices. Patient(s): Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis. Intervention(s): Adhesion reduction by administration of NOCC vs. Ringer's lactate at the conclusion of the initial surgical procedure, as assessed at second-look laparoscopy. The NOCC was applied as 200 mL of a 1{\%} NOCC gel that was tamped in place, followed by 100 mL of 2{\%} NOCC solution. Efficacy was assessed by covariate analysis. Main Outcome Measure(s): Safety and postoperative adhesion formation. Result(s): Groups did not differ in age, ethnicity distribution, height, weight, or body mass index. No deaths or serious adverse events were attributable to NOCC, and no adverse events were definitively or probably related to NOCC administration. Adhesions recurred at 61{\%} of sites in controls and 38{\%} of sites in NOCC recipients. De novo grade 1a and 1b adhesions tended to occur more commonly in controls than NOCC recipients. Adhesion extent and severity at second look were also less in NOCC recipients. Conclusion(s): Intraperitoneal use of NOCC gel and solution appears to be safe. Despite the small sample, strong trends were identified for reduction of occurrence, extent, and severity of adhesion recurrence and de novo adhesion formation.",
keywords = "Adhesions, Laparoscopy, N,O-carboxymethylchitosan",
author = "Diamond, {Michael Peter} and Anthony Luciano and Johns, {D. Alan} and Randall Dunn and Phillip Young and Eric Bieber",
year = "2003",
month = "9",
day = "1",
doi = "10.1016/S0015-0282(03)00759-3",
language = "English (US)",
volume = "80",
pages = "631--636",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - Reduction of postoperative adhesions by N,O-carboxymethylchitosan

T2 - A pilot study

AU - Diamond, Michael Peter

AU - Luciano, Anthony

AU - Johns, D. Alan

AU - Dunn, Randall

AU - Young, Phillip

AU - Bieber, Eric

PY - 2003/9/1

Y1 - 2003/9/1

N2 - Objective: To examine the logistics, safety, and efficacy of N,O-carboxymethylchitosan (NOCC) in reducing adhesions in women. Design: Multicenter, prospective, randomized, reviewer-blinded clinical trial. Setting: Gynecologic practices. Patient(s): Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis. Intervention(s): Adhesion reduction by administration of NOCC vs. Ringer's lactate at the conclusion of the initial surgical procedure, as assessed at second-look laparoscopy. The NOCC was applied as 200 mL of a 1% NOCC gel that was tamped in place, followed by 100 mL of 2% NOCC solution. Efficacy was assessed by covariate analysis. Main Outcome Measure(s): Safety and postoperative adhesion formation. Result(s): Groups did not differ in age, ethnicity distribution, height, weight, or body mass index. No deaths or serious adverse events were attributable to NOCC, and no adverse events were definitively or probably related to NOCC administration. Adhesions recurred at 61% of sites in controls and 38% of sites in NOCC recipients. De novo grade 1a and 1b adhesions tended to occur more commonly in controls than NOCC recipients. Adhesion extent and severity at second look were also less in NOCC recipients. Conclusion(s): Intraperitoneal use of NOCC gel and solution appears to be safe. Despite the small sample, strong trends were identified for reduction of occurrence, extent, and severity of adhesion recurrence and de novo adhesion formation.

AB - Objective: To examine the logistics, safety, and efficacy of N,O-carboxymethylchitosan (NOCC) in reducing adhesions in women. Design: Multicenter, prospective, randomized, reviewer-blinded clinical trial. Setting: Gynecologic practices. Patient(s): Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis. Intervention(s): Adhesion reduction by administration of NOCC vs. Ringer's lactate at the conclusion of the initial surgical procedure, as assessed at second-look laparoscopy. The NOCC was applied as 200 mL of a 1% NOCC gel that was tamped in place, followed by 100 mL of 2% NOCC solution. Efficacy was assessed by covariate analysis. Main Outcome Measure(s): Safety and postoperative adhesion formation. Result(s): Groups did not differ in age, ethnicity distribution, height, weight, or body mass index. No deaths or serious adverse events were attributable to NOCC, and no adverse events were definitively or probably related to NOCC administration. Adhesions recurred at 61% of sites in controls and 38% of sites in NOCC recipients. De novo grade 1a and 1b adhesions tended to occur more commonly in controls than NOCC recipients. Adhesion extent and severity at second look were also less in NOCC recipients. Conclusion(s): Intraperitoneal use of NOCC gel and solution appears to be safe. Despite the small sample, strong trends were identified for reduction of occurrence, extent, and severity of adhesion recurrence and de novo adhesion formation.

KW - Adhesions

KW - Laparoscopy

KW - N,O-carboxymethylchitosan

UR - http://www.scopus.com/inward/record.url?scp=0042335996&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0042335996&partnerID=8YFLogxK

U2 - 10.1016/S0015-0282(03)00759-3

DO - 10.1016/S0015-0282(03)00759-3

M3 - Article

VL - 80

SP - 631

EP - 636

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 3

ER -