Patient-assessed outcome up to three months in a randomised controlled trial comparing laparoscopic with open groin hernia repair

MRC Laparoscopic Groin Hernia Trial Group

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

The objective was to compare laparoscopic with open groin hernia repair in respect of patient-assessed outcome up to three months post-operatively. As part of a multicentre pragmatic trial 716 patients were recruited in 13 UK hospitals and randomly assigned to receive laparoscopic or open repair. Most participants were men (95%) with unilateral hernias (92.5%) which were inguinal (98.5%). Questionnaires were completed one week, one month, and three months after surgery. The principal endpoints were groin pain and return to usual social activities. The other outcomes were hernia-specific questions and the SF-36, EQ-5D and HADS measures. All analyses were by intention to treat. At one week and one month, respectively 10.3% and 13.9% fewer people in the laparoscopic group had groin pain and 27.7% and 37.2% fewer had numbness (all P <0.001). Return to usual social activities was quicker in the laparoscopic group (P = 0.01). The laparoscopic group also had significantly more favourable scores at one week in five SF-36 subscales (physical functioning (P <0.001), social functioning (P = 0.004), role physical (P <0.001), role mental (P = 0.003) and pain (P <0.001)), the EQ-5D utility score (P = 0.003) and the depression subscale of HADS (P = 0.001), and at one month in two SF-36 subscales (physical functioning (P = 0.01) and role physical (P = 0.01)). There was no detectable advantage by three months. Our findings that short-term outcome was better for patients allocated laparoscopic repair are consistent with other trials.
Original languageEnglish
Pages (from-to)73-79
Number of pages7
JournalHernia
Volume4
Issue number2
DOIs
Publication statusPublished - 1 Jun 2000

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Groin
Herniorrhaphy
Randomized Controlled Trials
Hernia
Pain
Pragmatic Clinical Trials
Intention to Treat Analysis
Hypesthesia
Multicenter Studies
Depression
4-amino-4'-hydroxylaminodiphenylsulfone

Keywords

  • inguinal hernia
  • randomised controlled trial
  • health status measures

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Patient-assessed outcome up to three months in a randomised controlled trial comparing laparoscopic with open groin hernia repair. / MRC Laparoscopic Groin Hernia Trial Group.

In: Hernia, Vol. 4, No. 2, 01.06.2000, p. 73-79.

Research output: Contribution to journalArticle

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abstract = "The objective was to compare laparoscopic with open groin hernia repair in respect of patient-assessed outcome up to three months post-operatively. As part of a multicentre pragmatic trial 716 patients were recruited in 13 UK hospitals and randomly assigned to receive laparoscopic or open repair. Most participants were men (95{\%}) with unilateral hernias (92.5{\%}) which were inguinal (98.5{\%}). Questionnaires were completed one week, one month, and three months after surgery. The principal endpoints were groin pain and return to usual social activities. The other outcomes were hernia-specific questions and the SF-36, EQ-5D and HADS measures. All analyses were by intention to treat. At one week and one month, respectively 10.3{\%} and 13.9{\%} fewer people in the laparoscopic group had groin pain and 27.7{\%} and 37.2{\%} fewer had numbness (all P <0.001). Return to usual social activities was quicker in the laparoscopic group (P = 0.01). The laparoscopic group also had significantly more favourable scores at one week in five SF-36 subscales (physical functioning (P <0.001), social functioning (P = 0.004), role physical (P <0.001), role mental (P = 0.003) and pain (P <0.001)), the EQ-5D utility score (P = 0.003) and the depression subscale of HADS (P = 0.001), and at one month in two SF-36 subscales (physical functioning (P = 0.01) and role physical (P = 0.01)). There was no detectable advantage by three months. Our findings that short-term outcome was better for patients allocated laparoscopic repair are consistent with other trials.",
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AU - Scott, N.W.

AU - Grant, A.M.

AU - Ross, S.J.

AU - Smith, A.

AU - Macintyre, I.M.C.

AU - O'Dwyer, P.J.

AU - MRC Laparoscopic Groin Hernia Trial Group

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PY - 2000/6/1

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N2 - The objective was to compare laparoscopic with open groin hernia repair in respect of patient-assessed outcome up to three months post-operatively. As part of a multicentre pragmatic trial 716 patients were recruited in 13 UK hospitals and randomly assigned to receive laparoscopic or open repair. Most participants were men (95%) with unilateral hernias (92.5%) which were inguinal (98.5%). Questionnaires were completed one week, one month, and three months after surgery. The principal endpoints were groin pain and return to usual social activities. The other outcomes were hernia-specific questions and the SF-36, EQ-5D and HADS measures. All analyses were by intention to treat. At one week and one month, respectively 10.3% and 13.9% fewer people in the laparoscopic group had groin pain and 27.7% and 37.2% fewer had numbness (all P <0.001). Return to usual social activities was quicker in the laparoscopic group (P = 0.01). The laparoscopic group also had significantly more favourable scores at one week in five SF-36 subscales (physical functioning (P <0.001), social functioning (P = 0.004), role physical (P <0.001), role mental (P = 0.003) and pain (P <0.001)), the EQ-5D utility score (P = 0.003) and the depression subscale of HADS (P = 0.001), and at one month in two SF-36 subscales (physical functioning (P = 0.01) and role physical (P = 0.01)). There was no detectable advantage by three months. Our findings that short-term outcome was better for patients allocated laparoscopic repair are consistent with other trials.

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