Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results

Ahonen-Siirtola, Mirella; Nevala, Terhi; Vironen, Jaana; Kössi, Jyrki; Pinta, Tarja; Niemeläinen, Susanna; Keränen, Ulla; Ward, Jaana; Vento, Pälvi; Karvonen, Jukka; Ohtonen, Pasi; Mäkelä, Jyrki; Rautio, Tero

doi:10.1007/s10029-018-1784-2

Cited by 25 publications

(33 citation statements)

References 28 publications

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“…The perioperative parameters and short-term postoperative complications up to the 1-month-control visit have been reported in our previous publication [25].…”

Section: Resultsmentioning

confidence: 91%

“…This trial compares hybrid and standard LIVHR with primary outcome measures of seroma formation at 1 month and hernia recurrence at the 1-year follow-up. Our shortterm results have been published previously [25]. The present study aims to find out whether a hybrid operation with diminished postoperative seroma formation has any impact on hernia recurrence compared to LIVHR.…”

mentioning

confidence: 75%

“…Eleven Finnish hospitals participated in the study. The perioperative parameters and short-term postoperative complications have been published previously [25]. The study was approved by the local ethical committee of each hospital.…”

Section: Methodsmentioning

confidence: 99%

“…Postoperative complications were graded according to the Clavien-Dindo scale [26]. Specific characteristics of the surgical technique are described in our previous article [25].…”

Section: Methodsmentioning

confidence: 99%

“…The secondary measures are long-term complications, pain (VAS) and QoL. The randomisation process and its implementation are presented elsewhere [25].…”

Section: Study Outcomementioning

confidence: 99%

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Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results

et al. 2019

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Purpose Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR. Methods This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured. Results At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014). Conclusion Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL. Trial Registry: Clinical trial number NCT02542085.

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“…The perioperative parameters and short-term postoperative complications up to the 1-month-control visit have been reported in our previous publication [25].…”

Section: Resultsmentioning

confidence: 91%

mentioning

confidence: 75%

Section: Methodsmentioning

confidence: 99%

“…Postoperative complications were graded according to the Clavien-Dindo scale [26]. Specific characteristics of the surgical technique are described in our previous article [25].…”

Section: Methodsmentioning

confidence: 99%

“…The secondary measures are long-term complications, pain (VAS) and QoL. The randomisation process and its implementation are presented elsewhere [25].…”

Section: Study Outcomementioning

confidence: 99%

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Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results

et al. 2019

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Primary Fascial Closure During Minimally Invasive Ventral Hernia Repair

2020

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Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial

Christoffersen

Westen

Rosenberg

et al. 2020

British Journal of Surgery

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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).

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Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results

Abstract: NCT02542085.

Cited by 25 publications

References 28 publications

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results

Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results

Primary Fascial Closure During Minimally Invasive Ventral Hernia Repair

Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial

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