Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial
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Closure of the fascial defect during laparoscopic umbilical hernia repair : a randomized clinical trial. / Christoffersen, M W; Westen, M; Rosenberg, J; Helgstrand, F; Bisgaard, T.
I: British Journal of Surgery, Bind 107, Nr. 3, 2020, s. 200-208.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Closure of the fascial defect during laparoscopic umbilical hernia repair
T2 - a randomized clinical trial
AU - Christoffersen, M W
AU - Westen, M
AU - Rosenberg, J
AU - Helgstrand, F
AU - Bisgaard, T
N1 - © 2020 BJS Society Ltd Published by John Wiley & Sons Ltd.
PY - 2020
Y1 - 2020
N2 - BACKGROUND: The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair.METHODS: This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years.RESULTS: Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047).CONCLUSION: Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).
AB - BACKGROUND: The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair.METHODS: This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years.RESULTS: Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047).CONCLUSION: Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).
KW - Adult
KW - Aged
KW - Double-Blind Method
KW - Female
KW - Follow-Up Studies
KW - Hernia, Umbilical/surgery
KW - Herniorrhaphy/methods
KW - Humans
KW - Laparoscopy/methods
KW - Male
KW - Middle Aged
KW - Quality of Life
KW - Recurrence
KW - Surgical Mesh
KW - Time Factors
KW - Wound Closure Techniques
U2 - 10.1002/bjs.11490
DO - 10.1002/bjs.11490
M3 - Journal article
C2 - 31971616
VL - 107
SP - 200
EP - 208
JO - British Journal of Surgery
JF - British Journal of Surgery
SN - 0007-1323
IS - 3
ER -
ID: 257200002